Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | February 5, 2019 |
| End Date: | April 30, 2021 |
| Contact: | Raymond T Chung, MD |
| Email: | RChung@partners.org |
| Phone: | 6177247562 |
This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV
negative recipient patients, with preemptive, interventional treatment with 12 weeks of
commercially available DAA therapy to prevent HCV transmission upon transplantation.
negative recipient patients, with preemptive, interventional treatment with 12 weeks of
commercially available DAA therapy to prevent HCV transmission upon transplantation.
The goal of this study is to determine if preoperative dosing and sustained administration of
pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis
C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.
pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis
C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.
Inclusion Criteria:
- Met MGH transplant center criteria, listed for lung transplant
- Able to sign informed consent
Exclusion Criteria:
- Pregnant or nursing (lactating) women
- HIV positivity
- Any contra-indication to lung transplantation per center protocol
- For study patients in whom Epclusa® therapy is being considered, exclusion criteria
includes patients on the following p-glycoprotein inducers or moderate to potent CYP
inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital,
oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
- For study patients in whom MavyretTM therapy is being considered, exclusion criteria
includes patients on the following medications who cannot stop therapy: carbamazepine,
rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Raymond T Chung, MD
Phone: 617-724-3836
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